Medical device regulation professional

Senior Regulatory Affairs Specialist

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. The ideal candidate will be responsible for managing all regulatory activities including product certification and compliance, as well as supporting the ongoing maintenance, audit and continuous improvement of specific elements of our Quality Management System.


* Manage the regulatory process and vigilance reporting.
* Prepare submissions for required markets, coordinating input from other stakeholders and tracking clearance to completion.
* Maintain technical files for cleared products.
Skill requirements include:

* A third-level degree in a relevant field with significant experience in medical devices.

* A postgraduate qualification in Quality Assurance is advantageous along with experience of active medical devices.

* Significant regulatory affairs experience including international processes. In-depth knowledge of product certification testing requirements for active Medical Devices is essential.
Promote best practice, knowledge of QSR standards and strong project management skills are also required.

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